This product is contained in CLEARFIL PORCELAIN BOND (K871636) and CLEARFIL VENEER BOND (K900690) which has been submitted to FDA as 510k notifications and permitted to be marketed already.

AI/ML Overview

The provided text (K012730) describes a 510(k) premarket notification for a medical device called "CLEARFIL PORCELAIN BOND ACTIVATOR." However, this document does not contain information about acceptance criteria, device performance metrics, or any studies using AI or human readers.

The 510(k) submission is specifically to:

Alter the name and address of the manufacturer from Kuraray Co., Ltd. to Kuraray Medical Inc.
Confirm that the device is substantially equivalent to a previously cleared predicate device (CLEARFIL PORCELAIN BOND ACTIVATOR by Kuraray Co., Ltd., K925404).

The document explicitly states that "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes" and "This device is essentially the same as CLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Co., Ltd. (K925404). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL PORCELAIN BOND ACTIVATOR."

Because of this, there are no new studies or performance data presented in this specific 510(k) summary. All performance and safety data would have been part of the original K925404 submission for the predicate device.

Therefore, I cannot provide the requested information based on the input text. The questions about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not addressed in this document.

Summary

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SEP 1 3 2001

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" with a geometric design. The word "KURARAY" is printed in a sans-serif font below the letter "K". The logo is simple and modern.

12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Facsimile: +81-6-348-2552

KURARAY MEDICAL INC.

K012730

510(k) SUMMARY

1. Submitter

1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) Contact person	Koji NishidaDENTAL MATERIAL DEPARTMENT
4) Date	August 9, 2001
5) Contact person in U.S.A.	Masaya Sasaki30th Fl. Metlife Building, 200 Park Avenue, New York,NY 10166Telephone : (212)-986-22301-(800)-879-1676Facsimile : (212)-867-3543

2. Name of Device

1) Proprietary Name	CLEARFIL PORCELAIN BOND ACTIVATOR
2) Classification Name	Resin tooth bonding agent (21 CFR 872.3200)
3) Common/Usual Name	Activator for bonding systems for restorations

3. Predicate device:

Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on The aim of 510(k) submission is to alter the name and address of October 1st 2001. manufacturer, and not to intend other changes.

The predicate device is as follow.

CLEARFIL PORCELAIN BOND ACTIVATOR by Kuraray Co., Ltd. (K925404) 1.

4. Description for the premarket notification

This product is contained in CLEARFIL PORCELAIN BOND (K871636) and CLEARFIL VENEER BOND (K900690) which has been submitted to FDA as 510k notifications and permitted to be marketed already.

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5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Co., Ltd. (K925404).

Repair of porcelain or porcelain fused-to-metal crowns and bridges

1. Restoration of gingival porcelain areas where bonding to porcelain is necessary
1. Increased retention of porcelain inlays, onlays, crowns and veneers
1. Increased retention of composite inlays and onlays
1. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Co., Ltd. (K925404). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL PORCELAIN BOND ACTIVATOR.

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Image /page/2/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged to follow the curve of the circle.

SEP 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166

Re: K012730

Trade/Device Name: Clearfil Porcelain Bond Activator Regulation Number: 872.3200 Regulation Name: A.ctivator for Bonding Systems for Restorations Regulatory Class: II Product Code: KLE Dated: August 9, 2001 Received: August 14, 2001

Dear Ms. Sasaki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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Page 2 - Ms. Sasaki

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outhal the Act's requirements, including, but not limited to: registration 1 od intilet comply was a 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet rerair product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) I mis letter notification. The FDA finding of substantial equivalence of your device to a promative nearleted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 If you desire specific as for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski

Timo A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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[CLEARFIL PORCELAIN BOND ACTIVATOR, Kuraray Medical Inc.]

K012730

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL PORCELAIN BOND ACTIVATOR

Indications for Use

CLEAFIL PORCELAIN BOND ACTIVATOR is indicated for the following applications:

1. Repair of porcelain or porcelain fused-to-metal crowns and bridges
1. Restoration of gingival porcelain areas where bonding to porcelain is necessary
1. Increased retention of porcelain inlays, onlays, crowns and veneers
1. Increased retention of composite inlays and onlays

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Susan Runse

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510k) Number _

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.